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     256  0 Kommentare Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis - Seite 2

    Under the terms of the agreement with Gilead, Galapagos is entitled to an approval milestone of $100 million for the approval of filgotinib in the US, which was included in the Galapagos cash burn guidance. Following this CRL, Galapagos revises its full year 2020 operational cash burn guidance to between €490 and €520 million.

    About the Filgotinib Collaboration1
    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in rheumatoid arthritis, and other inflammatory indications. The companies have multiple clinical study programs for filgotinib in inflammatory diseases, including the FINCH Phase 3 program in rheumatoid arthritis, the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies in uveitis and in small bowel and fistulizing Crohn’s disease. More information about clinical trials with filgotinib can be accessed at: www.clinicaltrials.gov.


    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

    Contacts Galapagos
    Investors:                                                                Media:
    Elizabeth Goodwin                                                  Carmen Vroonen

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    Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis - Seite 2   Mechelen, Belgium; 19 August 2020, 01.25 CET; regulated information – Galapagos (Euronext & Nasdaq: GLPG) announces today that Gilead Sciences, Inc. (Nasdaq: GILD) received a complete response letter (CRL) from the U.S. Food and Drug …